Evaluation of Standard TED Stocking vs. Reparel Bioactive Garment on Postoperative Leg Swelling, Pain and DVT Rates After Hip Replacement Surgery
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 50
- Locations
- 2
- Primary Endpoint
- HOOS Jr. Score
Study Overview
Brief Summary
This randomized, prospective study compares the effectiveness of a novel bioactive garment (Reparel Leg Sleeve) versus standard TED compression stockings in reducing postoperative leg swelling, pain, and deep vein thrombosis (DVT) rates following total hip arthroplasty. The study aims to determine whether the bioactive garment improves patient comfort and recovery outcomes compared to traditional stockings.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Care Provider)
Eligibility Criteria
- Ages
- 18 Years to 89 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age 18-89
- •Undergoing primary unilateral total hip replacement
- •BMI < 40
- •Able to follow postoperative protocol
- •English speaking
Exclusion Criteria
- •Age <18 or >90
- •Physical inability to use stockings
- •Allergy to silicone/polyester
- •Active DVT
- •History of vascular bypass on operative limb (e.g., Fem-Pop, Fem-Fem)
- •Inability to comply with post-op/rehab
- •Lymphedema
Outcomes
Primary Outcomes
HOOS Jr. Score
Time Frame: Postoperative Weeks 6 and 12
The Hip Disability and Osteoarthritis Outcome Score, Junior (HOOS Jr.) evaluates hip function and patient-reported symptoms following total hip arthroplasty.
VR-12 Score
Time Frame: Postoperative Week 12
The Veterans RAND 12-Item Health Survey (VR-12) evaluates patient-reported physical and mental health status.
HSS Satisfaction Score
Time Frame: Postoperative Week 12
The Hospital for Special Surgery (HSS) Satisfaction Score assesses patient satisfaction following hip replacement surgery.
Forgotten Joint Score
Time Frame: Postoperative Week 12
The Forgotten Joint Score measures the extent to which patients are aware of their hip joint during daily activities, reflecting functional recovery.
Pain Score (VAS)
Time Frame: Postoperative Weeks 2, 6, and 12
Pain will be measured using the Visual Analog Scale (VAS), a standard 0-10 numeric rating scale. Patients will report pain levels during routine postoperative follow-up visits or via validated questionnaires.
Secondary Outcomes
- Leg Swelling (Clinical Evaluation)(Postoperative Weeks 2, 6, and 12)
- Incidence of Deep Vein Thrombosis(Up to 12 weeks after surgery)
- Postoperative Narcotic Use(Collected at 2, 6, and 12 weeks after surgery)
- Study Questionnaire Responses(Weeks 2, 6, and 12 postoperatively)